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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Burger King, Weibel Drive, Midfield, AL, USA

Total all time reports:  1
Latest report: July 22, 2020 11:37 AM
Undercooked Food, Burger King, Weibel Drive, Midfield, AL, USA

Undercooked Food

July 22, 2020 11:37 AM

“Decided to go to there The food was undercooked. See Less
Reported By SafelyHQ.com User

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September 3, 2020 7:00 PM

“Company name: AJR Trading LLC
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Possible presence of methanol
FDA Recall date: September 03, 2020
Recall details: AJR Trading is voluntarily recalling 2,004 units of lot 20DF8307 of bio aaa Advance Hand Sanitizer currentl... See Morey in US distribution, packaged in 480 mL bottles, to the consumer level. This lot of bio aaa Advance Hand Sanitizer has been tested and meets all appropriate specifications and tests. However, in an abundance of caution, these units are being recalled because of possible presence of methanol in other lots of bio aaa Advance Hand Sanitizer.

Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands may be at risk; young children who accidently ingest them and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, AJR Trading has not received reports of adverse events related to this recall.

The product is used as a hand sanitizer to reduce bacteria when soap and water is not available and is packaged in 480 mL plastic bottles UPC 7502272121085.  AJR Trading is recalling lot 20DF8307, expiration date April 2022. The product can be identified by the images below. Product was distributed in Miami beginning in April 2020. AJR Trading is notifying its customers by phone calls, e-mails, and letters.  AJR Trading is arranging for refund and destruction of recalled products.

Consumers/distributors/retailers that have the above listed lots of bio aaa Hand Sanitizer, which is being recalled, should stop using or distributing the products immediately and mail the products to AJR Trading at the following address for refund: 814 Ponce de Leon Blvd, suite 218. Coral Gables, FL. 33134. Consumers with questions regarding this recall can contact AJR Trading by phone insert 305-302-8416 or e-mail to ajrtrading15@gmaill.com Monday to Friday from 10:00 am to 5:00 pm Central Time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Sun Pharmaceutical Industries
Brand name: Riomet ER
Product recalled: Metformin Hydrochloride for Extended-Release Oral Suspension
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: September 23, 2020
Recall details: Sun Pharmace... See Moreutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.  RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.  The affected RIOMET ER™ is the following lot:

- RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL. Lot # AB06381. NDC #10631-019-17. Expiration Date: 10/2021. Number of Units: 747 cartons.

The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product was distributed nationwide to wholesale customers.

SUN PHARMA is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have RIOMET ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.

Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at fda.gov

Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 4, 2020 7:00 AM

“Company name: RLC Labs, Inc
Brand name: RLC Labs
Product recalled: Nature-Throid® and WP Thyroid®
Reason of the recall: Product may be sub potent
FDA Recall date: September 02, 2020
Recall details: RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in... See Moreall strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from  six (6) lots  by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

RLC Labs, Inc. has not received any reports of adverse events related to this recall. Nature-Throid® and WP Thyroid® (thyroid tablets, USP) is composed of liothyronine and levothyroxine, and are used to treat hypothyroidism (underactive thyroid). The products subject to recall are packaged in 30, 60, 90, 100 and 1,000 count bottles. To best identify the product, the NDC’s, Product Descriptions, Lot Numbers and Expiration Dates are listed in the link below.

These lots were distributed nationwide in the USA to RLC Labs, Inc.’s direct accounts, including healthcare professionals and retail pharmacies. RLC Labs, Inc. is proactively notifying its wholesalers by email, mail and phone to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking Nature-Throid® and WP Thyroid® should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

Insects in Food, Italist Pizza Pasta Bar, проспект Соборності, Kyiv, Ukraine

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September 5, 2020 12:03 PM

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September 7, 2020 8:36 PM

“The CFIA announced the recall of Frank brand Milk Chocolate Covered Raisins by Canadian Tire Corporation of Canada from the marketplace due to undeclared peanut.

- Frank Milk Chocolate Covered Raisins (300 g). UPC: 6 26394 33920 7. Best Before 2021 MA 07, Lot: 07EUA | Best Before 2021 MA 13, Lot... See More: 13EUA | Best Before 2021 JL 07, Lot: 07GUB | Best Before 2021 APR 21, Lot: 21DUB | Best Before 2021 JL 08, Lot: 08GUB

Check the full recall details on the CFIA website: inspection.gc.ca

Source: CFIA
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Reported By SafelyHQ.com User

September 16, 2020 9:38 PM

“The FSIS announced the recall of approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products by Willow Tree Poultry Farm, Inc due to misbranding and an undeclared allergen. The products may contain walnuts, a known allergen, which are not declared on the product labels. There have been n... See Moreo confirmed reports of adverse reactions due to consumption of these products to date.

FSIS advises consumers not to eat the recalled products and to throw them away or return them to the place of purchase. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” and was produced on Sept. 2, 2020. The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, the District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, Rhode Island, Vermont and Virginia. The following products are subject to recall:

- 15-oz. clear, plastic containers labeled as “Willow Tree Premium White Meat CHICKEN SALAD Classic” with a sell by date of “9/30/20” and a time stamp of 13:00:00 through 17:00:00 on the containers’ cellophane lid.

Check the full recall details on the FSIS website fsis.usda.gov

Source: FSIS
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Reported By SafelyHQ.com User

September 1, 2020 4:36 PM

“Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of Ancient Grain Jackfruit Bowl sold at Publix because it may contain an undeclared allergen, FISH (anchovies). People who have an allergy or severe sensitivity to FISH (anchovies) run the risk of serious or life-threatening allergic... See Morereaction if they consume these products.

The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.

- Eat Fresco Ancient Grain Jackfruit Bowl. GTIN: 85898800510. Lot/Exp. Date: ALL

Individuals with an allergy or sensitivity to fish (anchovies) should not consume this product. Households that include individuals with an allergy or sensitivity to fish (anchovies) should dispose of the product or return it to the place of purchase for a refund.

Consumers with questions may contact Fresco Foods, Inc. at (813) 551-2100.

Check the full recall details on corporate.publix.com

Source: Publix
See Less
Reported By SafelyHQ.com User

August 31, 2020 4:00 PM

“Company name: Mylan N.V.
Brand name: Mylan
Product recalled: Tranexamic Acid and Amiodarone HCl injections
Reason of the recall: Vials potentially packaged in incorrect cartons
FDA Recall date: August 31, 2020
Recall details: Mylan N.V. (NASDAQ: MYL) today announced that its U.S.-based Mylan In... See Morestitutional LLC business is conducting a voluntary nationwide recall to the hospital/clinic level of four lots of Amiodarone HCl Injection, USP 450 mg/9 mL, packaged in cartons of 10 single-dose 9 mL vials and Tranexamic Acid Injection, USP 1000 mg/10 mL, packaged in cartons of 10 single-dose 10 mL vials.

These batches are being recalled due to the potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP. The individual vials contained within the cartons are accurately labeled as Amiodarone HCl Injection, USP or Tranexamic Acid Injection, USP. Both of these medications are administered in a hospital setting only by trained healthcare professionals. To date, Mylan has not received any reports of adverse events related to this recall.

Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP are used to treat different conditions. If Tranexamic acid is administered to a patient in place of Amiodarone or vice versa, it could present a risk to patient safety. If Amiodarone HCl Injection is inadvertently administered it could result in low blood pressure and irregular heartbeat, including lower than expected heart rate, which could have immediate life-threatening effects on cardiac function. If treatment with Amiodarone HCl Injection, when needed, is delayed this could result in continued irregular heartbeat and potential life-threatening effects on cardiac function.

If Tranexamic Acid Injection is inadvertently administered it could result in adverse events, including blood clotting, seizures, hypersensitivity reactions, visual disturbances, and dizziness. If treatment with Tranexamic Acid Injection, when needed, is delayed this could result in limited to serious and life-threatening bleeding events. Amiodarone HCl Injection, USP is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients’ refractory to other therapy. Tranexamic acid injection is indicated in patients with hemophilia for short term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

These batches were distributed nationwide in the USA to wholesalers and hospital/clinical pharmacies between April 2020 and July 2020. The recalled batch information is as follows:

NDC #: 67457-153-09
Material Description: Amiodarone HCl Injection, USP
Strength: 450 mg/9 mL
Carton Size: 10 x 9 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

NDC #: 67457-197-10
Material Description: Tranexamic Acid Injection, USP
Strength: 1000 mg/10 mL
Carton Size: 10 x 10 mL single-dose vials
Lot No.: 191207 / 191221 / 191223 / 200120
Expiry: Nov. 2021 / Nov. 2021 / Nov. 2021 / Nov. 2021

Mylan is notifying its wholesalers and hospital/clinic pharmacies by letter and is arranging for return of recalled products to Stericycle. Wholesalers and hospital/clinic pharmacies that have product which is being recalled should stop use/further distribution or dispensing.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

September 5, 2020 12:01 PM

“Company name: CorgioMed LLC
Brand name: Leafree
Product recalled: Hand sanitizer
Reason of the recall: Product is labeled as edible alcohol.
FDA Recall date: September 03, 2020
Recall details: CorgioMed, LLC is voluntarily recalling all lots of Leafree Instant Hand Sanitizer-Aloe Vera, within e... See Morexpiry to the consumer level.  The products are being recalled because they are labeled as “EDIBLE ALCOHOL”. Leafree Hand Sanitizer is an alcohol-based hand rub to be applied externally to reduce bacteria on the skin when soap and water are not available.

Risk Statement: Ingesting hand sanitizer, which is intended for topical use, may result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Young children may experience a sharp decrease in blood sugar which may result in death. Pregnant women who ingest alcohol have experienced birth defects and developmental disabilities. Nursing mothers who ingest alcohol in above moderate levels may see developmental, growth and sleep pattern damages in their babies and may experience impaired judgement and ability to safely care for their child.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.  The labeling of this product as ‘edible alcohol’ may promote this behavior. The product is used as a hand sanitizer and is packaged in 100 ml (UPC #6970495860325), 300 ml (UPC #69705860318) and 500 ml (UPC #6970495860301) bottles. 

Product was distributed Nationwide via CorgioMed website. CorgioMed LLC is notifying its distributors and customers by email and is arranging for return or disposal of all recalled products. Distributors and Consumers with questions regarding this recall can contact CorgioMed LLC by emailing to: contact@corgiomed.comor phone: 301-978-3898 from September 1st to September 30th, 2020. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User